EUCTR2009-016178-33-AT进行中（未招募）不适用
A Phase III, multicentre, international, randomised, parallel group, double blind cardiovascular safety study of BI 10773 (10 mg and 25 mg administered orally once daily) compared to usual care in type 2 diabetes mellitus patients with increased cardiovascular risk.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 7,000
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.Diagnosis of type 2 diabetes mellitus prior to informed consent; 2.Male and female patients on diet and exercise regimen who are drug-naïve or pre-treated with any background therapy. Antidiabetic therapy has to be unchanged for 12 weeks prior to randomization. If insulin is part of the background therapy, the insulin total daily prescribed dose should not be changed within the 12 weeks prior to randomisation by more than 10% daily from the baseline value at randomisation; 3.HbA1c of =7.0% and =10% at Visit 1 (screening) for patients on background therapy or HbA1c of =7.0% and =9.0% At Visit 1 (screening) for drug-naïve patients; 4.Age =18 years; 5. BMI =45 kg/m2 at Visit 1 (Screening); 6.Signed and dated written informed consent by date of Visit 1; 7. In addition to the above described criteria, patients must have high CV risk, defined as at least one of the following:
- •Confirmed history of myocardial infarction (>2 months prior to informed consent)
- •Evidence of multivessel coronary artery disease, in 2 or more major coronary arteries, irrespective of the revascularization status, i.e.
- •Evidence of a single vessel coronary artery disease; •Last episode of unstable angina (>2 months prior informed consent) with confirmed evidence of coronary multivessel or single vessel disease.
- •History of ischemic or haemorrhagic stroke (>2 months prior to informed consent)
- •Presence of peripheral occlusive arterial artery disease (symptomatic or not ) documented by either : previous limb angioplasty, stenting or bypass surgery; or previous limb or foot amputation due to circulatory insufficiency; or angiographic evidence of significant (> 50%) peripheral artery stenosis in at least one limb; or evidence from a non-invasive measurement of significant (>50% or as reported as hemodynamically significant) peripheral artery stenosis in at least one limb; or ankle brachial index of < 0.9 in at least one limb.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 7000
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 2100
排除标准
- •1.Uncontrolled hyperglycaemia with a glucose level >240 mg/dl (>13.3 mmol/L) after an overnight fast during placebo run-in and confirmed by a second measurement (not on the same day)
- •2.Indication of liver disease, defined by serum levels of either ALT (SGPT), AST (SGOT), or alkaline phosphatase above 3 x upper limit of normal (ULN) as determined during screening and/or run in phase.
- •3.Planned cardiac surgery or angioplasty within 3 months
- •4.Impaired renal function, defined as GFR<30 ml/min (severe renal impairment, MDRD formula) as determined during screening and/or run in phase.
- •5.Bariatric surgery within the past two years and other gastrointestinal surgeries that induce chronic malabsorption
- •6.Blood dyscrasias or any disorders causing haemolysis or unstable Red Blood Cell (e.g. malaria, babesiosis, haemolytic anemia)
- •7.Medical history of cancer (except for basal cell carcinoma) and/or treatment for cancer within the last 5 years
- •8.Contraindications to background therapy according to the local label
- •9.Treatment with anti-obesity drugs (e.g., sibutramine, orlistat) 3 months prior to informed consent or any other treatment at the time of screening (i.e., surgery, aggressive diet regimen, etc.) leading to unstable body weight
- •10.Current treatment with systemic steroids at time of informed consent or change in dosage of thyroid hormones within 6 weeks prior to informed consent or any other uncontrolled endocrine disorder except T2DM
- •11.Pre-menopausal women (last menstruation = 1 year prior to informed consent) who:
- •- are nursing or pregnant or
- •- are of child-bearing potential and are not practicing an acceptable method of birth control, or do not plan to continue using this method throughout the study and do not agree to submit to periodic pregnancy testing during participation in the trial. Acceptable methods of birth control include tubal ligation, transdermal patch, intra uterine devices/systems (IUDs/IUSs), oral, implantable or injectable contraceptives, sexual abstinence (if allowed by local Authorities), double barrier method and vasectomised partner
- •12.Alcohol or drug abuse within the 3 months prior to informed consent that would interfere with trial participation or any ongoing condition leading to a decreased compliance to study procedures or study drug intake
- •13.Intake of an investigational drug in another trial within 30 days prior to intake of study medication in this trial. Or participating in another trial (involving an investigational drug and/or follow-up).
- •14.Any other clinical condition that would jeopardize patients safety while participating in this clinical trial
- •15.Acute coronary syndrome, stroke or TIA within 2 months prior to informed consent.
研究者
相似试验
尚未招募
3 期
BI 10773 Cardiovascular Outcomes Trial in Type 2 Diabetes Mellitus PatientsDiabetes Mellitus, Type 2SLCTR/2011/008Boehringer Ingelheim India Pvt Ltd
进行中（未招募）
不适用
A Phase III, multicentre, international, randomised, parallel group, double blind cardiovascular safety study of BI 10773 (10 mg and 25 mg administered orally once daily) compared to usual care in type 2 diabetes mellitus patients with increased cardiovascular risk.The study will be performed in patients with type 2 diabetes mellitus and high cardiovascular risk who have insufficient glycaemic control despite diet and exercise and are either treatment naïve or receiving any antidiabetic background therapy.Drug-naïve is defined as absence of any antidiabetic therapy for 12 weeks prior to randomisation.MedDRA version: 12.1Level: LLTClassification code 10067585Term: Type 2 diabetes mellitusEUCTR2009-016178-33-FRBoehringer Ingelheim France4,000
进行中（未招募）
不适用
BI 10773 Cardiovascular outcome event trial in Type 2 Diabetes Mellitus patientsThe study will be performed in patients with type 2 diabetes mellitus and high cardiovascular risk who have insufficient glycaemic control despite diet and exercise and are either treatment naïve or receiving any antidiabetic background therapy.Drug-naïve is defined as absence of any antidiabetic therapy for 12 weeks prior to randomisation.MedDRA version: 18.1Level: PTClassification code 10067585Term: Type 2 diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disordersEUCTR2009-016178-33-DKBoehringer Ingelheim Pharmaceuticals, Inc.7,000
进行中（未招募）
不适用
BI 10773 Cardiovascular outcome event trial in Type 2 Diabetes Mellitus patientsThe study will be performed in patients with type 2 diabetes mellitus and high cardiovascular risk who have insufficient glycaemic control despite diet and exercise and are either treatment naïve or receiving any antidiabetic background therapy.Drug-naïve is defined as absence of any antidiabetic therapy for 12 weeks prior to randomisation.MedDRA version: 17.0Level: PTClassification code 10067585Term: Type 2 diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disordersEUCTR2009-016178-33-HUBoehringer Ingelheim RCV GmbH & Co. KG7,000
进行中（未招募）
不适用
A Phase III, multicentre, international, randomised, parallel group, double blind cardiovascular safety study of BI 10773 (10 mg and 25 mg administered orally once daily) compared to usual care in type 2 diabetes mellitus patients with increased cardiovascular risk.The study will be performed in patients with type 2 diabetes mellitus and high cardiovascular risk who have insufficient glycaemic control despite diet and exercise and are either treatment naïve or receiving any antidiabetic background therapy.Drug-naïve is defined as absence of any antidiabetic therapy for 12 weeks prior to randomisation.MedDRA version: 18.1Level: PTClassification code 10067585Term: Type 2 diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disordersEUCTR2009-016178-33-PTnilfarma, Lda.7,000